Safety catheter

ABSTRACT

A device and method for positioning a catheter to establish a fluid access site into the vasculature of a patient includes a luer assembly having a cannula or catheter, a shuttle assembly having a stylet for stiffening the catheter, and a holder assembly having an actuator for providing controlled retraction into a handle. The safety catheter comprises a flash window that allows a clinician to view when the vasculature of a patient has been properly accessed and to confirm that the stylet has been fully retracted into a safe position.

PRIORITY

This application is a Divisional of application Ser. No. 13/544,914,which was filed Jul. 9, 2012 which is currently pending and which is aContinuation of application Ser. No. 12/874,200, filed Sep. 1, 2010,which is now U.S. Pat. No. 8,216,188, and which is acontinuation-in-part of application Ser. No. 12/494,108 filed Jun. 29,2009, which is now U.S. Pat. No. 8,216,187. The contents of applicationSer. Nos. 13/544,914, 12/874,200 and 12/494,108 are incorporated hereinby reference.

FIELD

Embodiments of the present invention relate, in general, to medicalcatheters, and, in particular, to devices and methods of use relating tomedical catheters having passive safety systems, controlled needleretraction, and visualization windows.

BACKGROUND

Fluid access into the vasculature of a patient may be necessary, ordesirable, for any of several different reasons. When such access isdesirable, a fluid flow path is generally established between anextracorporeal fluid source and the vasculature. Moreover, when aninfusion protocol is involved that requires periodic injections, anestablished fluid access site that can be repetitively used for asequence of different injections may be required. Establishing such anaccess site, however, can be problematic.

SUMMARY OF THE INVENTION

For the present invention, a safety catheter includes an actuator thatinteracts with a handle, a shuttle assembly, and a luer assembly.Together, these components cooperate with each other to position aflexible cannula, which is part of the luer assembly, in fluidcommunication with the vasculature of a patient. In this cooperation,the shuttle assembly interacts with the luer assembly so that a stylet,which is part of the shuttle assembly, stiffens the cannula during itsinsertion into the vasculature. Once the cannula (i.e. luer assembly)has been properly and effectively established in fluid communicationwith the vasculature, the stylet (i.e. shuttle assembly) may be safelywithdrawn into a chamber that is formed inside the handle. As envisionedfor the present invention, however, the actuator controls exactly whenthis withdrawal of the shuttle assembly and its stylet into the chamberis accomplished.

In a preferred embodiment of the safety catheter, the actuator ismounted on the handle of the safety catheter, and it is disposed foraxial movement thereon between a proximal position and a distalposition. Structurally, the actuator includes an annular shaped basemember that is positioned on the handle and is centered on thelongitudinal axis of the handle. It also has a pair of opposed railsthat extend, in parallel, from the base member in a distal direction.Additionally, there is a pair of opposed living hinges on the actuatorthat are respectively positioned outwardly at a radial distance from thebase member. Also, at this same radial distance from the base member, apair of opposed arcuate bands interconnect the living hinges.Additionally, a dorsal pad is mounted on the base member.

During an assembly of the safety catheter, a plurality of resilientfingers that extend distally on the handle are engaged with the shuttleassembly. The luer assembly is then positioned to hold the fingersagainst the shuttle assembly. Specifically, the purpose of thisengagement is to stationarily maintain the shuttle assembly in a distalposition, relative to the chamber in the handle. Also, with thisengagement, the stylet of the shuttle assembly is positioned in thecannula of the luer assembly to stiffen the cannula. Further, theactuator is positioned between the handle and the luer assembly, and itis substantially positioned over the shuttle assembly. In the assemblyof the safety catheter, the actuator is located in its proximal positionon the handle, and latches on the actuator grip the luer assembly tohold it on the shuttle assembly.

Operationally, once the stylet has been used to properly insert theflexible cannula of the luer assembly into the vasculature of thepatient, the actuator is moved from its proximal position into itsdistal position. During this movement, several structural interactionsoccur simultaneously. For one, as the actuator is distally advanced, thelatches release the luer assembly and the rails on the actuator push onthe luer assembly to separate it from the shuttle assembly. For another,also during this advancement, the living hinges are compressed betweenstops on the handle to bias the actuator for a return back to itsproximal position. Also, importantly, the base member itself urgesagainst the resilient fingers of the handle to maintain their engagementwith the shuttle assembly. This advancement of the actuator can continueuntil the arcuate bands that interconnect the living hinges make contactwith stops on the handle to prevent any further distal advancement ofthe actuator.

When the actuator has been moved to its distal position, the luerassembly is effectively separated from the shuttle assembly.Nevertheless, the shuttle assembly and its stylet will remain distallyextended from the catheter, and can still be manipulated by the handle,as long as the actuator is maintained in its distal position. This allchanges, however, when the actuator is released. Upon a release of theactuator by the operator, the bias in the living hinges returns theactuator to its proximal position. This return of the actuator alsoreleases the base member of the actuator from the resilient fingers onthe handle. Thus, the fingers are no longer restrained by either theluer assembly or by the base member of the actuator. Consequently, whenthe actuator returns to its proximal position, the fingers on the handlerelease the shuttle assembly, and this causes the shuttle assembly to bewithdrawn into the chamber of the handle by a spring drive.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings incorporated in and forming a part of thespecification illustrate several aspects of the present disclosure, andtogether with the description serve to explain the principles of theinvention; it being understood, however, that the described embodimentsare not limited to the precise arrangements shown. In the drawings, likereference numerals refer to like elements in the several views. In thedrawings:

FIG. 1 is a side view of one version of a safety catheter shown with ashield engaged with a holder of the safety catheter;

FIG. 2 is an exploded perspective view of the safety catheter of FIG. 1having a luer assembly, a shuttle assembly, and a holder assembly.

FIG. 3 is a side cross-section view of the luer assembly of the safetycatheter shown in FIG. 2;

FIG. 4 is a side cross-section view of the shuttle assembly of thesafety catheter shown in FIG. 2;

FIG. 5 is a side cross-section view of the holder assembly of the safetycatheter shown in FIG. 2;

FIG. 6 is a perspective view of the shield shown in FIG. 2;

FIG. 7 is a perspective view of the holder shown in FIG. 2;

FIG. 8 is a perspective view of the luer or hollow outer portion shownin FIG. 2;

FIG. 9 is a perspective view of the body top shown in FIG. 2;

FIG. 10 is a perspective view of the shuttle body shown in FIG. 2; FIG.11 is a side view of the stylet shown in FIG. 2;

FIG. 11 is a side view of the stylet shown in FIG. 2;

FIG. 12 is a perspective view of the eyelet shown in FIG. 2;

FIG. 13 is a perspective view of the spring shown in FIG. 2;

FIG. 14 is a side view of the catheter shown in FIG. 2;

FIG. 15 is a perspective view of the one-way valve shown in FIG. 2;

FIG. 16 is a perspective view of the filter or stop shown in FIG. 2;

FIG. 17 is a perspective view of the actuator shown in FIG. 2;

FIG. 18 is a side cross-section view of the safety catheter of FIG. 1shown in a pre-use configuration with the shield in place;

FIG. 19 is a side cross-section view of the safety catheter of FIG. 18,shown rotated ninety degrees;

FIG. 19 a is a side view of the safety catheter of FIG. 19;

FIG. 20 is a side cross-section view of the safety catheter of FIG. 1,shown with the shield removed in a configuration for accessing thevasculature of a patient;

FIG. 21 is a side cross-section view of the safety catheter of FIG. 20,shown rotated ninety degrees;

FIG. 21 a is a side view of the safety catheter of FIG. 20;

FIG. 22 is a side cross-section view of the safety catheter of FIG. 1,shown with the actuator and the luer assembly distally advanced;

FIG. 23 is a side cross-section view of the safety catheter of FIG. 22,shown rotated ninety degrees;

FIG. 23 a is a side view of the safety catheter of FIG. 23;

FIG. 24 is a side cross-section view of the safety catheter of FIG. 1,shown with the luer assembly disengaged from the shuttle assembly andhandle assembly;

FIG. 25 is a side cross-section view of the safety catheter of FIG. 24,shown rotated ninety degrees;

FIG. 25 a is a side view of the safety catheter of FIG. 25;

FIG. 26 is a side cross-section view of the safety catheter of FIG. 1,shown with the shuttle assembly retracted into the handle assembly;

FIG. 27 is a side cross-section view of the safety catheter of FIG. 26,shown rotated ninety degrees; and

FIG. 27 a is side view of the safety catheter of FIG. 27.

DETAILED DESCRIPTION

The following description of certain examples should not be used tolimit the scope of the present invention. Other features, aspects, andadvantages of the versions disclosed herein will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out theinvention. As will be realized, the versions described herein arecapable of other different and obvious aspects, all without departingfrom the invention. Accordingly, the drawings and descriptions should beregarded as illustrative in nature and not restrictive.

As shown in the figures, versions illustrated herein may useful as adevice for manipulating a stylet and/or any other stiffening orpenetration element to position a catheter in fluid communication withthe vasculature of a patient, and for subsequently concealing the styletto prevent inadvertent “sticks” with the stylet. In one version, theretraction of the stylet or needle cannula is performed in a controlledmanner, where controlled retraction may limit or mitigate tissue damagethat can be associated with uncontrolled retraction that occursautomatically without input from a clinician.

When a catheter is used to establish a fluid access site into thevasculature of a patient, the catheter is generally flexible. Oncepositioned, a flexible cannula may be beneficial in reducing patientdiscomfort and in minimizing tissue damage. The flexible catheter,however, may need to be stiffened for insertion so that the distal endof the catheter, or cannula, can be passed through tissue and positionedin the vasculature. This stiffening can be accomplished, for example, byusing a stylet that can be selectively inserted into the lumen of thecatheter to stiffen the catheter during insertion. After the stiffenedcatheter has been properly positioned in the vasculature, the stylet canbe removed from the catheter to leave the flexible catheter in fluidcommunication with the vasculature for delivery or removal of fluidtherefrom.

Versions of the safety catheter described herein provide for a stylet orneedle cannula that is passively retracted from a flexible catheterafter the flexible catheter is properly positioned. Passively retractingthe stylet after positioning the catheter may reduce the risk ofaccidental needle sticks by safely securing the stylet upon completionof the catheter insertion. In at least one version, a passive releaserefers to automatically releasing a needle or shuttle assembly forretraction. However, it will be appreciated that upon passive release,where a needle assembly is free to pass into a secured position, a usermay still control the timing of the actual release to provide controlledretraction. Versions herein provide for the controlled retraction of thestylet after positioning the flexible catheter, where controlledretraction may allow the stylet to be safely secured without causingtissue damage that may be associated with an abrupt or uncontrolledretraction.

Versions described herein are directed to a catheter device and systemthat can be positioned to establish a single fluid access site formultiple infusions of a fluid medicament into the vasculature. Thesafety catheter system may be configured with a single-step operationsuch that the flexible catheter is separated from the stylet in anautomated manner and the stylet is concealed after placement of thecatheter to prevent accidental needlesticks and can include an actuatorand/or other release device, mechanism, or component to facilitatecontrolled retraction.

Referring to FIGS. 1 and 2, one version of a safety catheter 10 isprovided that is configured for insertion into the vasculature of apatient. The safety catheter 10 may be used to establish a single fluidaccess site into the vasculature of the patient that can be repetitivelyor sequentially used by extracorporeal fluid sources such as, but notlimited to, a hypodermic syringe or IV pump (not shown). Generally,versions of the safety catheter 10 are configured to stiffen a flexiblecatheter or cannula 22 for insertion into the vasculature of a patient.Once the cannula 22 is properly positioned, the safety catheter 10 isconfigured to passively and/or automatically release a stylet 36, or anyother suitable stiffening and/or penetration element, for withdrawalfrom the catheter. In one version, upon passive release of the stylet 36from the cannula 22, the stylet 36 is configured for controlledretraction via an actuator 80 (FIG. 17) into a handle body 52 such thatthe sharp distal tip 42 of the stylet 36 is concealed to preventaccidental needlesticks. Controlled retraction of the stylet 36, afterpassive release from the cannula 22, may reduce or prevent tissue damageassociated with an uncontrolled or abrupt retraction.

Referring to FIG. 1, one version of a safety catheter 10 is shown in apre-deployment or pre-use configuration. More specifically, the safetycatheter 10 is shown having a handle 12 with a textured surface 13 and acap or shield 14. As illustrated, the shield 14 is engaged with thehandle 12 to prevent exposure and contamination of the safety catheter10. The shield 14 may have any suitable configuration designed toprevent exposure of the cannula 22 and stylet 36 (FIG. 2). Shield 14comprises any suitable shape or grip and may be transparent orsemitransparent to facilitate visualization of the cannula 22 and stylet36. Referring to FIG. 6, the shield 14 may include flats 15 to preventthe safety catheter 10 from rolling on a flat surface and to facilitateautomated engagement with the handle 12. The shield 14 may furtherinclude one or a plurality of projections 17, or any other suitablecoupling, configured to engage the handle 12 to provide a securecoupling. The handle 12 may include any suitable corresponding couplingmeans.

Referring to FIG. 7, the handle 12 may have any suitable grippingsurface, such as textured surface 13, to facilitate handling, separationfrom the shield, operation, or the like. The handle 12 of the safetycatheter, in one version, includes an elongated handle body 52 that hasa proximal end 75 and a distal end 59. It is also formed with aninternal chamber 77. During operation, after a catheter has beeninserted into the vasculature of a patient, the handle body 52 isconfigured to retain the shuttle assembly 50 (FIG. 4) upon retraction ofthe stylet. The chamber 77 serves as a compartment for the stylet 36 toprevent accidental needlesticks and to prevent re-use.

In FIG. 1, the shield 14 is shown engaged with the handle 12, where anysuitable coupling between the shield 14 and the handle, including afriction fit, a snap fit, a threaded fit, shrink wrap, tamper evidentpackaging, or the like, is contemplated. In one version, once the shield14 is removed from the rest of the safety catheter 10 it cannot bereattached to the handle 12.

FIG. 2 illustrates an exploded view of the safety catheter 10 showingthe various components of one version of the safety catheter 10. Inaddition to the shield 14, the safety catheter 10 includes a luer orhollow body portion 20, a cannula 22, an eyelet 24, and a one-way valve26. In combination, these components comprise the luer assembly 16,which is shown and described in more detail with reference to FIG. 3.The safety catheter 10 further comprises a shuttle body assembly 50including a stylet 36, a filter plug 40, and a shuttle body 38, which isshown in more detail in FIG. 4. FIG. 2 further illustrates an explodedview of a handle assembly 63 comprising a body top 54 engaged with ahandle body 52 configured to retain a spring 70 therein. The handleassembly 63 further comprises an actuator 80 that is retained on thebody top 54 and is configured for longitudinal movement relativethereto. In the illustrated version, the luer assembly 16, the shuttleassembly 50, and the handle assembly 63 interact with one another inmultiple stages to provide a method of accurately and effectivelyaccessing the vasculature of a patient and reducing the risk ofaccidental needlesticks after the vasculature has been properlyaccessed.

FIG. 3 illustrates a more detailed cross-section view of the luerassembly 16. In one version, the cannula 22 comprises a proximal end 30and a distal end 34, where the proximal end 30 of the cannula 22 isbonded or otherwise attached to the eyelet 24. During assembly of theluer assembly 16, the eyelet 24, attached to the cannula 22, is fittedinto the proximal end 33 of the hollow body portion 20 such that thecannula 22 extends from the distal end 32 of the body portion 20, asillustrated. After engaging the cannula 22 and eyelet 24 with the bodyportion 20, a one-way valve 26 may be positioned inside the hollow bodyportion 20 proximate the eyelet 24. The one-way valve, or other suitableblocking and/or selectively accessible component, allows for the stylet36 of the shuttle assembly 50 (FIG. 4) to pass therethrough duringoperation of the safety catheter 10, but seals upon removal of thestylet 36 to prevent fluid from passing out of the luer assembly 16until a proper attachment with a syringe, or the like, is created. Inthis manner, the luer assembly 16 can remain within the vasculaturewhile various components are connected thereto via the one-way value forfluid delivery or removal.

The cannula 22 may be configured from any material, such as a flexible,bio-compatible elastomeric material, suitable for insertion into thevasculature of a patient. It will be appreciated that the cannula 22 maybe transparent or semi-transparent to allow visualization of blood orother fluid, have any suitable internal diameter, have a bias toward aparticular shape or configuration, be rigid or semi-rigid, and/or haveany suitable geometry at the distal end 33 thereof. In an alternateversion, the cannula 22 is integral with the eyelet 24 and/or one-wayvalve 26. It will be appreciated that the coupling of the components ofthe luer assembly 16 may be accomplished with any suitable engagementmeans such as with an adhesive, snap fit, friction fit, or the like.

Still referring to FIG. 3, the illustrated version of the hollow bodyportion 20 has a generally frustoconical shape tapering from theproximal end 33 to the distal end 32. The proximal end of the eyelet 24is configured to initially accept the stylet 36 and the distal end 46 ofthe shuttle body 38 during engagement of the luer assembly 16 andshuttle assembly 50. The outer surface of the luer or hollow bodyportion 20 may include a textured surface 35, such as a knurled surfaceor ridged surface, configured to be gripped by a user during operationof the safety catheter 10. The illustrated version of the hollow bodyportion 20 further comprises a pair of guides 28 configured to engageresilient fingers 66 on the body portion 54. It will be appreciated thatthe hollow body portion 20 may have any suitable shape or configurationdesigned to retain a cannula 22, to be advanced distally by a user,and/or to engage resilient fingers 66 associated with the body portion54. It will be appreciated that the hollow body portion 20 may includeany suitable number of guides 28, such as one or a plurality of guides,configured to engage a corresponding one or a plurality of resilientfingers 66. With reference to FIG. 1 and FIG. 8, the hollow body portion20 further comprises a pair of lateral flanges 81 configured to engagethe actuator 80 (FIG. 1), as will be described with more detail inreference to FIGS. 18-27 a.

The luer assembly 16 is configured for removal from the safety catheter10 and is designed to establish the site for fluid access into thevasculature of the patient. After the luer assembly has been properlypositioned within a patient's vasculature, the other components of thesafety catheter 10 will be removed such that an I.V. line, or the like,may be coupled with the luer assembly 16. It will be appreciated thatthe luer assembly 16 can include any suitable access means to thevasculature of a patient and/or means for coupling to a fluid deliveryor extraction means.

FIG. 4 illustrates a cross-section view of one version of the shuttleassembly 50 associated with safety catheter 10. The shuttle assembly 50comprises a shuttle body 38 having a proximal end 45 and a distal end46. In the illustrated version, the distal end 46 of the shuttle body 38comprises a channel 47 configured to retain a needle or stylet 36 havinga proximal end 44 and a distal end 42. The channel 47 extends proximallyfrom the distal end 46 of the shuttle body 38 along a portion of theshuttle body 38 and may be configured to retain the stylet 36 in anysuitable manner such as, for example, with an adhesive, a bonding, afriction fit, or any other suitable mechanical engagement. In oneversion, the stylet 36 is integral with the shuttle body 38. Theproximal end 45 of the shuttle body 38 comprises a laterally projectingannular flange 72 where, as shown in more detail in FIGS. 18-27 a, thespring 70 is retained between the annular flange 72 and an annularflange 61 on the body top 54.

In one version, the shuttle body 38 is configured from a transparent orsemi-transparent material to facilitate the visualization of fluid, suchas blood, therein. In one version, the shuttle body 38 further comprisesa cavity 49 defined by the outer wall of the shuttle body 38, theproximal end of the channel 47, and the filter plug 40. The stylet 36,in one version, has a lumen therethrough to facilitate the flow ofblood, or other fluid, from the distal tip 42 to the proximal end 46 andinto the cavity 49. Fluid entering the cavity 49 is trapped by thefilter plug 40. In one version, at least the portion of the shuttle body38 defining the cavity 49 is transparent, where upon accessing apatient's vasculature, blood will pass through the stylet 36 lumen andinto the cavity 49 such that a clinician can see that the vasculaturewas successfully accessed. The stylet 36 may have any suitableconfiguration, such as a beveled distal tip 42, to facilitate access toa patient's vasculature. The filter plug 40 is configured to preventfluid from passing out of the shuttle body 38 and may be integral withthe shuttle body or bonded to the shuttle body 38.

Still referring to FIG. 4, in the illustrated version, the shuttle body38 comprises a pair of opposing indents or flats 48 at or near thedistal end 46. The flats 48 are configured to engage a correspondingpair of projections 68 located on resilient arms 66 associated with thebody portion 54 (FIG. 5). It will be appreciated that the shuttle body38 may include any suitable number of flats 48, or other couplingfeature, configured to engage any suitable number of resilient arms 66and/or projections 68. It will be appreciated that the features of theillustrated components are provided by way of example only, where anycomponents suitable for facilitating the operation of the device inaccordance versions and methods described herein are contemplated.

During assembly of the luer assembly 16 (FIG. 3) and the shuttleassembly (FIG. 4), the distal tip 42 of the stylet 36 is inserted intothe proximal end 33 of the hollow body portion 20, through the one wayvalve 26, and through the flexible cannula 22. In this manner, thestylet 36 operates to stiffen the cannula 22 such that it can beinserted into the vasculature of the patient. The outer diameter of thestylet 36 may configured to be approximately the same as the innerdiameter of the cannula 22 such that a seal is created between thecannula 22 and stylet 36, however, any suitable relationship between thecannula 22 and stylet 36 is contemplated. The stylet 36 may be insertedthrough the cannula 22 until the distal end 46 of the shuttle body abutsor nears the proximal end of the one way valve 26. The safety catheter10 may include a cannula 22 and stylet 36 of any suitable length. In oneversion, the cannula 22 has a length that is approximately a centimetershorter than the length of the exposed stylet 36 when initially engagedwith the hollow body portion 20, however, any suitable dimension andrelationship is contemplated.

Generally, the shuttle assembly 50 is configured to provide sufficientrigidity to the cannula 22 of the luer assembly 16 until the luerassembly 16 is properly positioned. Once positioned, as shown in moredetail with reference to FIGS. 18-27 a, the luer assembly 16 is removedfrom the shuttle assembly by initially advancing the luer assembly 16with an actuator 80 and then manually removing the luer assembly 16completely from the rest of the safety catheter 10. Once the shuttleassembly 50 is removed, the cannula 22 may regain its flexibility andthe lumen of the cannula 22 will be clear for the transfer of fluidtherethrough.

Referring to FIG. 5, one version of a handle assembly 63 is illustratedcomprising a handle body 52, a body top 54, an actuator 80 (FIG. 17),and a spring 70. In the illustrated version, the body top 54 has agenerally cylindrical proximal end 58 that is configured to be insertedinto and bonded with the distal end 59 of the handle body 52. The bodytop 54 comprises an annular flange 61 having an outer portion 65 thatabuts the distal end 59 of the handle body when engaged. The body top 54and handle body 52 may have any suitable coupling including a bonding, asnap fit, a friction fit or, in an alternative embodiment, can beconfigured as an integral structure. The annular flange 61 of the bodytop 54 further comprises an inner portion 67 configured to retain aspring 70 within the handle body 52 in combination with the shuttle body38 of the shuttle assembly 50 (shown in FIGS. 18-27 a). Morespecifically, when the safety catheter 10 is assembled, the spring 70 ispositioned between the annular flange 72 on the shuttle body 38 (FIG. 4)and the inner portion 67 of the annular flange 61. In one version, thespring 70 is used to selectively provide a motive force that isconfigured to translate the shuttle assembly 50 relative to the handleassembly 63 during operation.

Referring to FIG. 9, a distal end 69 of the body top 54 comprises a pairof stops 71 projecting laterally outward from the body top 54. The stops71 define a pair of gaps 73 (FIG. 2) therebetween. An actuator 80 isconfigured to engage the distal end 69 of the body top 54 and isconfigured to translate axially relative thereto. The operation of theactuator 80 relative to the body top 54 will be described in more detailwith reference to FIGS. 17-27 a. Projecting proximally from the distalend 69 of the body top 54 are a pair of resilient arms 66 havingprojections 68 projecting laterally inward from the distal ends thereof.The resilient arms 66, in the illustrated version, are configured topivot as a living hinge about the connection point between the resilientarms 66 and the distal end 69 of the body top 54. The projections 68 areconfigured to engage the flats 48 on the shuttle body 38 of the shuttleassembly 50 as will be described in more detail with reference to FIGS.18-27 a.

Still referring to FIG. 5, one version of the body top 54 comprisesproviding a least a portion of the body top 54 that is transparent orsemi-transparent. In one version, when the handle assembly 63 is engagedwith the shuttle assembly 50, as will be described in more detailherein, the cavity 49 of the shuttle body 38 is aligned with the distalportion of the body top 54. With reference to FIGS. 20-21 a, byproviding a transparent distal portion 69 of the body top 54, whichaligns with the transparent portion of the shuttle body 38 covering thecavity 49, a flash window 62 is created that allows a clinician to seethat a patient's vasculature has been properly accessed. Providing aflash window 62 may eliminate a clinician having to guess as to theproper placement of the safety catheter 10 within the patient. Afteraccess to the vasculature has been confirmed, the safety catheter 10 maybe further operated in accordance with FIGS. 18-27 a. It will beappreciated that the luer assembly 16, the shuttle assembly 50, and thehandle assembly 63 are described by way of example only, where anysuitable components in any suitable configuration may be provided inaccordance with versions described herein. Components may be separate orintegral.

FIG. 6 illustrates a more detailed perspective view of the shield 14 andFIG. 7 illustrates a more detailed perspective view of the handle 12.FIG. 8 illustrates a more detailed perspective view of the hollow bodyportion 20. FIG. 9 illustrates a more detailed perspective view of thebody top 54. FIG. 10 illustrates a more detailed perspective view of theshuttle body 38, where in one version the shuttle body 38 comprises aflat 90. FIG. 11 illustrates a more detailed side view of the stylet 36.FIG. 12 illustrates a more detailed perspective view of the eyelet 24having, in one version a conical bevel 115. FIG. 13 illustrates a moredetailed side view of the spring 70. FIG. 14 illustrates a side view ofcannula 22, where in one version the cannula 22 comprises a distal end34 having a taper. FIG. 15 illustrates a more detailed perspective viewof the one-way valve 26. The one-way valve may be any suitable valve andmay include, for example, an annular collar 92 and a distal valveportion 94 having a slit 96 therein. The valve portion 94 may beconfigured from any suitable material such that the slit 96 is normallysealed unless penetrated, for example, by the stylet 36 or othervasculature access or delivery device or componet. It will beappreciated that any suitable valve or component that selectivelyrestricts the movement of fluid is contemplated. FIG. 16 illustrates amore detailed perspective view of the filter plug 40. It will beappreciated that filter plug 40 may be configured from any suitablematerial and may have any suitable configuration to prevent or obstructthe flow of fluid while allowing displacement of air or another gas.

FIG. 17 illustrates one version of an actuator 80 having a proximal end98 and a distal end 100. Actuator 80 comprises a base 95 having a dorsalthumb pad 97, a pair of distally extending rails 102, and a pair oflateral arms 104. The lateral arms 104 further comprise a pair of distalretention latches 106 having inwardly projecting lateral projections 108and a pair of proximal living hinges 110. The proximal ends of theliving hinges 110 are joined by a pair of crescent-shaped bands 112 thatform a partial annular band at the proximal end of the actuator 80. Theoperation of actuator 80 will be described in more detail with referenceto FIGS. 18-27 a.

With reference to FIGS. 18-27 a, one version of the operation of thesafety catheter 10 is illustrated. Generally, the operation of thesafety catheter is to transition the shuttle assembly 50 from a firstposition distal to the handle 12 to a second location inside the chamber77 of the handle 12. More specifically, in one version, when the shuttleassembly 50 in its first location on the handle 12, the safety catheter10 can be used to establish fluid access for the luer assembly 16 intothe vasculature of the patient. To maintain this fluid access site, theluer assembly 16 is separated from the rest of the safety catheter 10.After separating the luer assembly 16 from the rest of the safetycatheter 10, the shuttle assembly 50 is retracted to its second locationinside the handle 12. When in the second position, the sharp distal tip42 of the stylet 36 is effectively concealed inside the chamber 77 ofthe handle 12 to prevent inadvertent or accidental “sticks” by thestylet 36.

Referring FIGS. 18-19 a, the safety catheter 10 is shown in it pre-useconfiguration with the shield 14 engaged with the handle 12 toeffectively conceal the stylet 36. The safety catheter 10 may bepackaged in any suitable manner for the safe transport and/or storage onthe device.

FIGS. 20-21 a illustrate one version of the safety catheter 10 afterremoval of the shield 14 therefrom such that the safety catheter 10 isin a configuration designed to access the vasculature of a patient. Whenthe shuttle assembly 50 is in its first location, the luer assembly 16,the shuttle assembly 50 and the handle assembly 63 all interact witheach other. As illustrated, the stylet 36 of the shuttle assembly 50 isretained within the cannula 22 of the luer assembly 16 and the distalend 46 of the shuttle body 38 is positioned proximal to and adjacent theone-way valve 26 of the luer assembly 16 within the guides 28. Thestylet 36 extends distally from the shuttle body 38, through the one-wayvalve 26, and through the cannula 22. In the illustrated configuration,the stylet 36 stiffens the cannula 22 for insertion into the vasculatureof a patient.

At the same time, the proximal end 33 of the hollow body portion 20 ofthe luer assembly 16 is positioned over the resilient fingers 66 of thebody top 54, where the projections 68 on the resilient fingers areengaged, as best seen in FIG. 21, with the flats 48 of the shuttle body38. As illustrated in FIGS. 20 and 21, positioning the hollow bodyportion over the resilient arms 66 maintains the projections 68 withinthe flats 48 such that the shuttle assembly 50 is unable to moverelative to the handle assembly 63. This interaction between the luerassembly 16, the shuttle assembly 50, and the handle assembly 63effectively holds the shuttle assembly 50 in its first location relativeto the handle 12. While the shuttle assembly 50 is in its firstlocation, as shown in FIGS. 20-21 a, the spring 70 is compressed betweenthe annular flange 72 on the shuttle body 38 and the annular flange 61on body top 54. The spring 70 is configured to bias the shuttle assembly50 proximally into the holder 12, however, the retention of theprojections 68 of the resilient arms 66 within the flats 48 prevents theproximal retraction of the shuttle assembly 50. The spring 70 willremain compressed until the shuttle assembly is released from both theluer assembly 16 and the actuator 80.

Still referring to FIGS. 20-21 a, the actuator 80 is shown engaged withthe body top 54 and with the proximal end 33 of the hollow body portion20 of the luer assembly 16. More specifically, in the illustratedversion, the retention latches 106, having lateral projections 108, areengaged with the lateral flanges 81 on the hollow body portion 20. Inthis configuration, the luer assembly 16 is secured to the rest of thesafety catheter 10. As best seen in FIG. 21 a, the neck of the lateralarms 104 is positioned in the gaps 73 between the stops 71 on the bodytop 54. The bands 112 of the actuator substantially encircle the distalend of the body top 54 adjacent the annular band 61. In this position,the actuator 80 is secured to the body top 54 and the living hinges 110of the lateral arms 104 are in a relaxed position, where only the necksof the lateral arms 104 are positioned within the gaps 73 between thestops 71 of the body top 54.

As shown in FIGS. 20-21 a, the safety catheter is configured forinsertion into the vasculature of a patient. Upon insertion of thecannula 22 and stylet 36 into the patient, versions herein compriseconfirming that the safety catheter 10 has been properly positioned suchthat the luer assembly 16 is in fluid communication with the vasculatureof the patient. After successfully accessing the vasculature, blood willpass through the lumen of the stylet 36 and into the cavity 49 withinthe shuttle body 38. Because, in one version, the shuttle body 38 andsurrounding body top 54 are transparent, the blood will be visiblethrough this flash window. Visualizing blood through the flash window 62will indicate to the clinician that the vasculature has been properlyaccessed. The filter plug 40 confines the blood that enters into thecavity 49 of the shuttle assembly 50 and prevents blood born pathogensfrom leaking out of the safety catheter 10.

With reference to FIGS. 22-23 a, after the vasculature of a patient hasbeen accessed, the cannula 22 can be advanced beyond the distal tip 42of the stylet 36 and/or farther into the vasculature. Advancing thecannula 22 is accomplished by the clinician placing, for example, theirindex finger on the dorsal pad 97 (FIGS. 23-23 a) and distally advancingthe actuator. As the actuator 80 is advanced, the retention latches 106flex outward to disengage the lateral projections 108 from the lateralflanges 81 on the hollow body portion 20 of the luer assembly 16. Thisdisengagement frees the luer assembly 16 for removal from the rest ofthe safety catheter 10. Concurrently, as the actuator 80 is advanced,the rails 102 push the luer assembly 16 distally, thus advancing thecannula 22 farther into the vascular of the patient. As the luerassembly 16 is pushed distally by the actuator 80, the base 95 of theactuator moves to cover the resilient arms 66 (FIG. 23) of the body top54 such that the projections 68 are still retained within the flats 48on the shuttle body 38. In this position, the hollow body portion 20 ofthe luer assembly 16 is no longer retaining the resilient arms, however,the actuator 80 prevents the resilient arms from expanding laterally torelease and allow retraction of the shuttle assembly 50. In this mannerthe cannula 22 is extended further into the vasculature of a patientbefore allowing for the release of shuttle assembly. This configurationmay be beneficial as it allows the cannula 22 to be advanced with somestiffness, and to be repositioned if necessary, before the stylet 36 isretracted into the handle 12. As the actuator 80 is advanced, the livinghinges 110 (FIG. 23 a) on the actuator are drawn and contracted throughthe gaps 73 between the stops 71 of the body top 54. This contractionbiases the actuator 80 in a proximal direction, which upon release ofthe actuator, or by decreasing distal force on the actuator, will movethe actuator proximally.

With reference to FIGS. 24-25 a, after the cannula 22 has been furtheradvanced, the luer assembly 16 can removed from the rest of the safetycatheter 10 and remain within the vasculature of a patient. With theclinician's finger still positioned on the actuator 80, retaining thestylet 36 and shuttle assembly 50 in the first position, the luerassembly 16 may be guided off the stylet 36. As illustrated, theactuator 80 (FIG. 25) will maintain the projections 68 of the resilientarms 66 within the flats 48 until the actuator 80 is allowed to retract,thereby securing the shuttle assembly in the first position untilrelease of the stylet is desired.

With reference to FIGS. 26-27 a, the shuttle assembly 50 can be releasedfor retraction into the handle 12 at any time after the luer assembly 16has advanced. The luer assembly 16 can be partially or fully removedfrom the shuttle assembly 50 before allowing the shuttle assembly 50 toretract. Retraction is caused by the clinician releasing distal pressureon the actuator 80 such that the proximal bias of the living hinges 110(FIG. 27 a) urges the actuator proximally. As the actuator 80 movesproximally, the resilient arms 66 (FIG. 27), which are biased outwardly,are no longer retained within the flats 48. Once the resilient arms 66are able to expand laterally, the projections 68 on the resilient armsdisengage the flats 48. The shuttle body 38 of the shuttle assembly 50,once disengaged from the holder assembly 63, is urged to move proximallyby the spring 70 retained within the handle 12. The spring 70 will urgethe shuttle assembly 50 proximally into the chamber 77 of the handle 12,thus concealing the distal tip 42 of the stylet inside the handle 12.Concealing the stylet 36 in this manner can reduce the risks associatedwith accidental needle sticks. Once the shuttle assembly 50 is retainedwithin the handle 12, in one version, the distal tip 42 of the styletwill be aligned with the flash window 62 on the body top 54. In thisversion, the clinician will be able to see the distal tip 42 and knowthat the stylet 36 is properly retained and no longer presents a risk.

It will be appreciated that the method of operating the safety catheter10 is disclosed by way of example only, where steps may be provided inany suitable order with any suitable configuration of components toprovide for controlled retraction, a flash window to view when thevasculature of patient has been accessed, and/or a flash window to viewwhen a needle or stylet has been retracted to a safe position.

1. A method for manufacturing an actuator for separating a luer assemblyfrom a shuttle assembly while maintaining a stationary engagement of theshuttle assembly with a handle, and for subsequently retracting theshuttle assembly into a hollow chamber of the handle, the actuatorcomprising the steps of: mounting a base member on the handle for linearmovement along a longitudinal axis of the handle between a proximalposition and a distal position; affixing a pair of opposed rails ontothe base member, wherein the pair of opposed rails are alignedsubstantially parallel to each other and extend distally from the basemember in an axial direction, wherein, as the actuator is moved from itsproximal position to its distal position, the rails urge against theluer assembly to disengage the luer assembly from the shuttle assemblywhile the base member holds the handle on the shuttle assembly; andmounting a pair of opposed living hinges on the base member at a radialdistance therefrom, wherein the living hinges interact with the handleand are compressed during a distal movement of the actuator to bias theactuator for a return back into its proximal position, and wherein areturn of the actuator to its proximal position releases the engagementof the handle with the shuttle assembly for a retraction of the shuttleassembly into the chamber of the handle.
 2. A method as recited in claim1 wherein the base member is annular shaped and is centered on the axisto override the resilient fingers of the handle when the actuator ismoved from its proximal position to its distal position.
 3. A method asrecited in claim 1 wherein each living hinge is substantially “Y” shapedwith a pair of splayed arms, and wherein the bias of the living hinge iscreated when the arms are forced toward each other by structure on thehandle during a movement of the actuator toward its distal position, andfurther wherein each living hinge is positioned at a radial distancefrom the axis, and each living hinge has a first arm and a second arm,and wherein the actuator further comprises: a first arcuate bandinterconnecting the respective first ends of each living hinge; and asecond arcuate band interconnecting the respective second ends of eachliving hinge, wherein the first and second arcuate bands move from theradial distance and toward the axis during a movement of the actuatortoward its distal position for engagement with respective stops on thehandle to prevent further movement of the actuator in a distaldirection.
 4. A method as recited in claim 1 further comprising the stepof connecting a dorsal pad to the base member for manipulation of theactuator.
 5. A method as recited in claim 1 further comprising the stepof positioning a compressed spring between the shuttle assembly and thehandle for retracting the shuttle assembly into the hollow chamber ofthe handle when the actuator is returned from its distal position to itsproximal position.
 6. A method for assembling and operating a safetycatheter, wherein the safety catheter comprises an actuator, a handleformed with a chamber and with a plurality of resilient fingersextending distally on the handle away from the chamber, a shuttleassembly with a stylet, and a luer assembly with a cannula, the methodcomprising the steps of: engaging the plurality of resilient fingers ofthe handle against the shuttle assembly; positioning the luer assemblyover the fingers of the handle, with the fingers between the luerassembly and shuttle assembly, to hold the fingers against the shuttleassembly and to maintain the shuttle assembly in a distal positionrelative to the chamber in the handle with the stylet of the shuttleassembly inserted into the cannula of the luer assembly to stiffen thecannula; and locating the actuator in a proximal position on the handlefor gripping the luer assembly, to hold the luer assembly in astationary engagement with the shuttle assembly and with the handle,during an operation of the safety catheter.
 7. A method as recited inclaim 6 wherein the actuator is formed with an annular shaped basemember and wherein the locating step requires positioning the basemember on the handle with the base member centered on the longitudinalaxis of the handle.
 8. A method as recited in claim 7 wherein theactuator is formed with a pair of opposed rails extending in parallelfrom the base member in a distal direction.
 9. A method as recited inclaim 8 further comprising the steps of: inserting the stiffened cannulainto a target tissue; and pressing the actuator to move the actuator ina distal direction from its proximal position to a distal position. 10.A method as recited in claim 9 wherein the pressing step simultaneouslyaccomplishes the steps of: further advancing the stiffened cannula intothe target tissue; urging the rails of the actuator against the luerassembly to separate the luer assembly from the shuttle assembly; andmoving the base member over the fingers of the handle to maintain thehold of the handle fingers against the shuttle assembly.
 11. A method asrecited in claim 9 wherein the actuator includes a pair of opposedliving hinges mounted at a radial distance outwardly from the basemember, and wherein the pressing step further accomplishes the steps of:compressing the living hinges through an interaction of the livinghinges with the handle during a distal movement of the actuator on thehandle; and biasing the actuator during the compressing step for asubsequent proximal movement of the actuator.
 12. A method as recited inclaim 11 further comprising the step of releasing the actuator for areturn of the actuator back into its proximal position.
 13. A method asrecited in claim 12 wherein the releasing step simultaneouslyaccomplishes the steps of: removing the hold of the base member on thefingers of the handle to separate the shuttle assembly from the handle;and allowing the shuttle assembly to be retracted into the chamber ofthe handle with a consequent withdrawal of the stylet from the cannula.14. A method as recited in claim 13 wherein the retraction of theshuttle assembly into the chamber of the handle is accomplished by aspring, wherein the spring is compressed between the handle and theshuttle assembly during the assembly of the safety catheter.
 15. Amethod for using a safety catheter which comprises the steps of:inserting a stiffened cannula of a luer assembly into target tissue,wherein the cannula is stiffened by a stylet of a shuttle assembly, andwherein the shuttle assembly is mounted on a handle; pressing anactuator to further move the actuator in a distal direction, wherein thedistal movement of the actuator separates the luer assembly from theshuttle assembly while holding the shuttle assembly stationary on thehandle and maintaining the stylet in the cannula; and selectivelyreleasing the actuator after the pressing step to remove the hold of thehandle on the shuttle assembly to allow a retraction of the shuttleassembly into a hollow chamber of the handle while leaving the cannulawith the luer assembly in contact with the target tissue.
 16. A methodas recited in claim 15 wherein the actuator comprises an annular shapedbase member, a pair of opposed rails extending in parallel from the basemember in a distal direction, and a pair of opposed living hingesmounted at a radial distance outwardly from the base member, and whereinthe handle is formed with a hollow chamber and comprises a plurality ofresilient fingers extending distally on the handle away from thechamber, and further wherein the pressing step is accomplished manuallyto move the actuator in a distal direction on the handle from a proximalposition to a distal position.
 17. A method as recited in claim 16wherein the pressing step simultaneously accomplishes the steps of:further advancing the stiffened cannula into the target tissue; urgingthe rails of the actuator against the luer assembly to separate the luerassembly from the shuttle assembly; and moving the base member over thefingers of the handle to maintain the hold of the handle fingers againstthe shuttle assembly.
 18. A method as recited in claim 17 wherein theactuator includes a pair of opposed living hinges mounted at a radialdistance outwardly from the base member, and wherein the pressing stepfurther accomplishes the steps of: compressing the living hinges throughan interaction of the living hinges with the handle during a distalmovement of the actuator on the handle; and biasing the actuator duringthe compressing step for a subsequent proximal movement of the actuator.19. A method as recited in claim 18 further comprising the step ofreleasing the actuator for a return of the actuator back into itsproximal position.
 20. A method as recited in claim 19 wherein thereleasing step simultaneously accomplishes the steps of: removing thehold of the base member on the fingers of the handle to separate theshuttle assembly from the handle; and allowing the shuttle assembly tobe retracted into the chamber of the handle with a consequent withdrawalof the stylet from the cannula.